FDA Warning Letters, 483s and Recalls: November 2019
Warning letters
A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.
No warning letters outside tobacco are recorded for this month yet.
OAI inspections
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.
| Date | Facility | Product type | Country |
|---|---|---|---|
| Nov 28, 2019 | EL PEDREGAL S.A. | Food/Cosmetics | Peru |
| Nov 28, 2019 | Sociedad Agricola Saturno S.A. | Food/Cosmetics | Peru |
| Nov 28, 2019 | Vega Life Sciences | Drugs | India |
| Nov 27, 2019 | Abundant Foods, LLC | Food/Cosmetics | United States |
| Nov 26, 2019 | Celltrion Branchburg, LLC | Drugs | United States |
| Nov 26, 2019 | Lemond Trading Corp | Food/Cosmetics | United States |
| Nov 26, 2019 | Takeda Pharmaceutical Company Limited | Drugs | Japan |
| Nov 25, 2019 | Tender Corporation D/B/A Adventure Ready Brands | Drugs | United States |
| Nov 22, 2019 | Cosmaceutical Research Lab Inc. | Drugs | Canada |
| Nov 22, 2019 | Lathem Family Farms, Inc. | Food/Cosmetics | United States |
| Nov 22, 2019 | MPRX, Inc. | Drugs | United States |
| Nov 22, 2019 | Panexcell Clinical Lab PVT. LTD. | Drugs | India |
| Nov 22, 2019 | PRL Inc | Food/Cosmetics | United States |
| Nov 22, 2019 | Synchron Research Services Pvt. Ltd. | Drugs | India |
| Nov 22, 2019 | Synchron Research Services Pvt. Ltd. | Drugs | India |
| Nov 22, 2019 | The See Clear Company | Devices | United States |
| Nov 22, 2019 | Zsolt Szabo, M.D. | Drugs | United States |
| Nov 21, 2019 | Allied Vision Group Inc | Devices | United States |
| Nov 21, 2019 | Canton Laboratories Private Ltd. | Drugs | India |
| Nov 21, 2019 | EUCYT Laboratories LLC | Biologics | United States |
| Nov 21, 2019 | Morningstar Minerals LLC | Food/Cosmetics | United States |
| Nov 21, 2019 | Phi Sciences | Food/Cosmetics | United States |
| Nov 20, 2019 | AniCell Biotech, LLC | Veterinary | United States |
| Nov 20, 2019 | XENEX Disinfection Services Inc. | Devices | United States |
| Nov 19, 2019 | ActiveHerb Technology, Inc | Food/Cosmetics | United States |
| Nov 15, 2019 | PT. MegaSurya Mas | Drugs | Indonesia |
| Nov 15, 2019 | Shung Kee Food Co., Ltd. | Food/Cosmetics | United States |
| Nov 14, 2019 | Anamu Herbal Tea LLC | Food/Cosmetics | United States |
| Nov 14, 2019 | Kumar Organic Products Limited | Drugs | India |
| Nov 12, 2019 | Carie Boyd Pharmaceuticals LLC | Drugs | United States |
| Nov 12, 2019 | Pescaderia Catano | Food/Cosmetics | United States |
| Nov 12, 2019 | Raw Juicery, Inc. | Food/Cosmetics | United States |
| Nov 8, 2019 | BHP Holdings Inc | Food/Cosmetics | United States |
| Nov 8, 2019 | Fujian Yuxing Fruit&Vegetable Foodstuff Development Co.,Ltd. | Food/Cosmetics | China |
| Nov 8, 2019 | Kyowa Hakko Bio Co., Ltd. | Drugs | Japan |
| Nov 7, 2019 | Degania Medical Devices Pvt. Ltd. | Devices | India |
| Nov 7, 2019 | Hawaii Pharm LLC | Food/Cosmetics | United States |
| Nov 7, 2019 | Ufine Herbs, LLC | Food/Cosmetics | United States |
| Nov 6, 2019 | Jubilant Generics Limited | Drugs | India |
| Nov 1, 2019 | Centurion Medical Products, LP | Devices | United States |
| Nov 1, 2019 | Megsan Labs Private Limited | Drugs | India |
| Nov 1, 2019 | New Dawn Nutrition, Inc. | Food/Cosmetics | United States |
Most-cited Form 483 sections
The CFR sections FDA investigators cited most often in inspections that ended this month.
| CFR section | Observation | Citations |
|---|---|---|
| 21 CFR 1.502(a) | Maintain, follow FSVP | 32 |
| 21 CFR 211.192 | Written record of investigation incomplete | 25 |
| 21 CFR 820.198(a) | Lack of or inadequate complaint procedures | 25 |
| 21 CFR 123.6(b) | No HACCP plan | 23 |
| 21 CFR 820.100(a) | Lack of or inadequate procedures | 22 |
| 21 CFR 117.35(a) | Sanitary operations - Plant sanitation | 19 |
| 21 CFR 117.35(c) | Pest control | 18 |
| 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard | 17 |
| 21 CFR 123.11(b) | Sanitation monitoring documentation | 16 |
| 21 CFR 211.22(d) | Procedures not in writing, fully followed | 16 |
Class I recalls
Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.
| Date | Firm | Product type | Reason |
|---|---|---|---|
| Nov 29, 2019 | Laubscher Cheese Company, Ltd. | Food | Laubscher Cheese Company, LTD , has initiated a recall of Shredded Cheese, because samples of the shredded cheese were found positive for… |
| Nov 29, 2019 | Middlefield Original Cheese Coop | Food | Potential Listeria monocytogenes in the cheese. |
| Nov 29, 2019 | Middlefield Original Cheese Coop | Food | Potential Listeria monocytogenes in the cheese. |
| Nov 29, 2019 | Middlefield Original Cheese Coop | Food | Potential Listeria monocytogenes in the cheese. |
| Nov 29, 2019 | Middlefield Original Cheese Coop | Food | Potential Listeria monocytogenes in the cheese. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 26, 2019 | Fuji Food Products, Inc. | Food | RTE products potentially contaminated with Listeria monocytogenes. |
| Nov 25, 2019 | GE Healthcare, LLC | Devices | GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This… |
| Nov 25, 2019 | GE Healthcare, LLC | Devices | GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This… |
| Nov 21, 2019 | Medtronic Inc. | Devices | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a… |
| Nov 21, 2019 | Medtronic Inc. | Devices | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a… |
| Nov 21, 2019 | Medtronic Inc. | Devices | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a… |
| Nov 21, 2019 | Medtronic Inc. | Devices | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a… |
| Nov 20, 2019 | AuroMedics Pharma LLC | Drugs | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of… |
| Nov 20, 2019 | AuroMedics Pharma LLC | Drugs | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of… |
| Nov 20, 2019 | Kerry, Inc | Food | Undeclared milk allergen due to an incorrect back label being placed on the product. |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 19, 2019 | Philips Respironics, Inc. | Devices | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW… |
| Nov 15, 2019 | Tytek Medical Inc | Devices | A defect involving an occluded needle was discovered during a training exercise. |
| Nov 13, 2019 | Natures Rx | Drugs | Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. |
| Nov 12, 2019 | SIMPLOT-RDO LLC | Food | Undeclared soy (Edamame). |
| Nov 11, 2019 | Kettle Cuisine, LLC | Food | Soup labeled Creamy Cauliflower Parmesan Soup may contain undeclared fish and wheat |
| Nov 9, 2019 | International Marine Products Inc. Houston | Food | Potential to be contaminated with Listeria monocytogenes |
| Nov 9, 2019 | International Marine Products Inc. Houston | Food | Potential to be contaminated with Listeria monocytogenes |
| Nov 9, 2019 | International Marine Products Inc. Houston | Food | Potential to be contaminated with Listeria monocytogenes |
| Nov 8, 2019 | Cook Inc. | Devices | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with… |
| Nov 8, 2019 | Cook Inc. | Devices | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with… |
| Nov 8, 2019 | Cook Inc. | Devices | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with… |
| Nov 8, 2019 | Cook Inc. | Devices | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with… |
| Nov 8, 2019 | Med Man Distribution, Inc. | Drugs | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. |
| Nov 8, 2019 | Med Man Distribution, Inc. | Drugs | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | Cain Food Industries, Inc | Food | Possible contamination with Salmonella |
| Nov 5, 2019 | King Systems Corp. Dba Ambu, Inc. | Devices | Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right… |
| Nov 5, 2019 | Peekay International, Inc. | Food | Product contains undeclared sulfites. |
| Nov 5, 2019 | RMJV, LP DBA Fresh Creative Foods | Food | Potential Listeria monocytogenes contamination. |
| Nov 5, 2019 | RMJV, LP DBA Fresh Creative Foods | Food | Potential Listeria monocytogenes contamination. |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 5, 2019 | Russ Davis Wholesale, Inc. | Food | Products are being recalled because they may have the potential to be contaminated with Listeria monocytogenes |
| Nov 4, 2019 | Abundant Foods, LLC | Food | 5 lb. packages of Good For You Broccoli Salad are being voluntarily recalled because they may be contaminated with Listeria monocytogenes. |
| Nov 4, 2019 | Harrison Gypsum, LLC | Food | Possible contamination with Salmonella. |
| Nov 4, 2019 | Meijer Inc. | Food | Listeria Monocytogenes |
| Nov 4, 2019 | Meijer Inc. | Food | Listeria Monocytogenes |
| Nov 4, 2019 | Meijer Inc. | Food | Listeria Monocytogenes |
| Nov 4, 2019 | Mill Stream Corp. | Food | Low water phase salt. |
| Nov 4, 2019 | Pacific Coast Fruit Company | Food | The Winter Citrus Slaw Kit, item #71909, is recalled due to a potential contamination of Listeria monocytogenes. |
| Nov 4, 2019 | Taher, Inc. | Food | The Fresh Seasons, Fresh Veggie & Ranch Cup is being recalled because it contains cauliflower that was recalled by Mann Packing Co., Inc… |
| Nov 4, 2019 | Whole Foods Market | Food | Possible contamination with Listeria monocytogenes |
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